A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus

This study has been terminated.

(See termination reason in detailed description.)

Sponsor:

Pfizer

ClinicalTrials.gov Identifier:

NCT01470313

First Posted: November 11, 2011

Last Update Posted: January 29, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in disease activity will also be evaluated.

Efficacy of PD-0360324 based upon reduction of severity of symptoms as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) [ Time Frame: 12 Weeks ]

Subjects will receive PD-0360324 intravenously in 3 different cohorts. The cohorts will be evaluated in ascending fashion. The doses planned are 100 mg every other week for 3 months, 150 mg every other week for 3 months, and 200 mg every 4 weeks for 3 months.

Placebo Comparator: Placebo

Drug: Placebo

Placebo is normal saline. The timing of placebo administration will depend of the dosing frequency of the cohort (either every other week for 3 months or every 4 weeks for 3 months).

Detailed Description:

The trial was terminated prematurely on Oct 15, 2013 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

21 Years to 70 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male and/or female subjects between the ages of 21 to 70 who have a clinical diagnosis of either discoid cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus with or without systemic lupus erythematosus prior to screening that has been confirmed by evaluation of skin biopsy sample.

Active disease at both screening and baseline (Day 1) defined by a CLASI score of greater than or equal to 10.

Intolerance to antimalarial therapy or more than 3 months of antimalarial therapy with disease activity.

Exclusion Criteria:

Use of greater than or equal to 20 mg or prednisone (or equivalent) within 3 months of Day 1.

Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections

Subjects with evidence of past or active tuberculosis

Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470313